Ankle Osteoarthritis Clinical Trial
Official title:
Cryoneurolysis for Improvements in Pain, Activities of Daily Living and Quality of Life in Patients With Ankle Osteoarthritis
This will be an open-label trial to describe the effects of cryoneurolysis with iovera° on symptom relief in patients with painful Kellgren-Lawrence (KL) grade 2-4 ankle osteoarthritis (OA). The Foot and Ankle Outcome Score (FAOS) subscales will be used to assess outcomes at 6, 12 and 24 weeks after treatment.
The aim of this study is to assess clinically significant long-term symptomatic relief with
cryoneurolysis in people with unilateral ankle osteoarthritis (OA). The investigators will
treat 1) the Superficial Fibular Nerve (SFN), Sural Nerve (SN) and Saphenous Nerve and/or 2)
the Deep Fibular Nerve (DFN) with cryoneurolysis using the iovera° device. The primary study
endpoint, clinically significant improvement in pain 12 weeks after each treatment, will be
assessed using the FAOS pain subscale. If a participant is a non-responder (<20% improvement
in pain within the 12 weeks following baseline), then the other treatment will be offered
(e.g. if start with superficial group, then offer the DFN).
The secondary outcomes will be improvement in quality of life (FAOS-QoL), activities of daily
living (FAOS-ADL) and Numerical Rating Scale (NRS) for pain.
The tertiary outcome will be improvement in physical performance measures (40m fast-paced
walking test, standing balance test).
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